Evaluating in Vivo PARP-1 Expression With 18F-FluorThanatrace Positron Emission Tomography (PET/CT) in Breast Cancer
Primary Purpose
Breast Cancer
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
[18F]FluorThanatrace
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Participants will be ≥ 18 years of age
- Known or suspected (BIRADS 5 on imaging) primary breast cancer
- At least one breast lesion one breast lesion that is 1 cm or greater in size by standard imaging (e.g. mammography, ultrasound or breast MRI). Only one type of imaging is required to show a lesion of 1 cm or greater in order for the patient to be eligible to participate in this study. Patients that have a prior diagnosis of primary breast cancer in the opposite breast can be included.
- Willing to allow use orcollection of pathology tissue for the purposes of research from either clinical biopsy or surgical procedure (if adequate tissue is available) or research only biopsy
- Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.
Exclusion Criteria:
- Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential at screening.
- Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
- Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
Sites / Locations
- Abramson Cancer Center of the University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Outcomes
Primary Outcome Measures
Number of adverse events
Secondary Outcome Measures
Full Information
NCT ID
NCT03083288
First Posted
March 14, 2017
Last Updated
August 1, 2023
Sponsor
Abramson Cancer Center at Penn Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03083288
Brief Title
Evaluating in Vivo PARP-1 Expression With 18F-FluorThanatrace Positron Emission Tomography (PET/CT) in Breast Cancer
Official Title
Evaluating in Vivo PARP-1 Expression With 18F-FluorThanatrace Positron Emission Tomography (PET/CT) in Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 22, 2017 (Actual)
Primary Completion Date
February 22, 2025 (Anticipated)
Study Completion Date
February 22, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Up to 30 evaluable participants with known or suspected breast cancer (BIRADS 5 by imaging) will undergo FTT PET/CT imaging before primary surgery or neoadjuvant therapy. Patients undergoing neoadjuvant therapy may choose to have a second FTT PET/CT scan after the start of therapy (1 days to 3 weeks). FTT PET/CT uptake will be correlated with pathology measures and treatment response, in subjects undergoing neoadjuvant therapy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
[18F]FluorThanatrace
Intervention Description
[18F]FluorThanatrace is a radiotracer for PET/CT
Primary Outcome Measure Information:
Title
Number of adverse events
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants will be ≥ 18 years of age
Known or suspected (BIRADS 5 on imaging) primary breast cancer
At least one breast lesion one breast lesion that is 1 cm or greater in size by standard imaging (e.g. mammography, ultrasound or breast MRI). Only one type of imaging is required to show a lesion of 1 cm or greater in order for the patient to be eligible to participate in this study. Patients that have a prior diagnosis of primary breast cancer in the opposite breast can be included.
Willing to allow use orcollection of pathology tissue for the purposes of research from either clinical biopsy or surgical procedure (if adequate tissue is available) or research only biopsy
Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.
Exclusion Criteria:
Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential at screening.
Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth McDonald, MD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33884961
Citation
McDonald ES, Pantel AR, Shah PD, Farwell MD, Clark AS, Doot RK, Pryma DA, Carlin SD. In vivo visualization of PARP inhibitor pharmacodynamics. JCI Insight. 2021 Apr 22;6(8):e146592. doi: 10.1172/jci.insight.146592.
Results Reference
derived
Learn more about this trial
Evaluating in Vivo PARP-1 Expression With 18F-FluorThanatrace Positron Emission Tomography (PET/CT) in Breast Cancer
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